lly 102

lly 102
SPL v2
SPL
SPL Set ID f06fe167-8a16-14d9-e053-2a95a90a1a0f
Route
oral
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg)
Inactive Ingredients
povidone sodium starch glycolate type a potato starch, corn stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: GC101 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-06-01

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 325 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 mg (12 tablets) of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin

reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Purpose

Pain Reliever/Fever Reducer

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours. Do not take

    for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor
Other Information
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

Description

Acetaminophen 325 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for

children even if you do not notice any signs or symptoms.

Package Label

Active Ingredients

Acetaminophen 325 mg


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 mg (12 tablets) of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin

reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Purpose

Pain Reliever/Fever Reducer

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours. Do not take

    for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor
Other Information
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for

children even if you do not notice any signs or symptoms.

Package Label

Active Ingredients

Acetaminophen 325 mg


Advanced Ingredient Data


Raw Label Data

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